BEUDAMED
    FDA Adverse Event Death Summary report: N

    VISUALASE

    MDR report key: 8034680 · Received November 2, 2018

    Report

    Report Number
    1723170-2018-05467
    Event Type
    Death
    Date Received
    November 2, 2018
    Date of Event
    April 28, 2018
    Report Date
    November 2, 2018
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEX
    PMA / PMN Number
    K081656
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE. PLEASE NOTE THAT THE ACTUAL DATE OF DEATH WAS NOT PROVIDED IN THE LITERATURE ARTICLE. PLEASE NOTE THAT THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. ARTICLE CITATION INCLUDED. PLEASE NOTE THAT THE SYSTEM INFORMATION WAS NOT INCLUDED IN THE JOURNAL ARTICLE AND IS UNAVAILABLE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION: R NICK HERNANDEZ, ARTHUR CARMINUCCI, PURVEE PATEL, ERIC L HARGREAVES, SHABBAR F DANISH; MAGNETIC RESONANCE-GUIDED LASER-INDUCED THERMAL THERAPY FOR THE TREATMENT OF PROGRESSIVE ENHANCING INFLAMMATORY REACTIONS FOLLOWING STEREOTACTIC RADIOSURGERY, OR PEIRS, FOR METASTATIC BRAIN DISEASE, NEUROSURGERY, , NYY220, HTTPS://DOI.ORG/10.1093/NEUROS/NYY220 SUMMARY: BACKGROUND: IN PATIENTS WHO HAVE PREVIOUSLY UNDERGONE MAXIMUM RADIATION FOR METASTATIC BRAIN TUMORS, A PROGRESSIVE ENHANCING INFLAMMATORY REACTION (PEIR) THAT REPRESENTS EITHER TUMOR RECURRENCE OR RADIATION NECROSIS, OR A COMBINATION OF BOTH, CAN OCCUR. MAGNETIC RESONANCE-GUIDED LASER-INDUCED THERMAL THERAPY (LITT) OFFERS A MINIMALLY INVASIVE TREATMENT OPTION FOR THIS PROBLEM. OBJECTIVE: TO REPORT OUR SINGLE-CENTER EXPERIENCE USING LITT TO TREAT PEIRS AFTER RADIOSURGERY FOR BRAIN METASTASES. METHODS: PATIENTS WITH PROGRESSIVE, ENHANCING REACTIONS AT THE SITE OF PRIOR RADIOSURGERY FOR METASTATIC BRAIN TUMORS AND WHO HAD A KARNOFSKY PERFORMANCE STATUS OF =70 WERE ELIGIBLE FOR LITT. THE PRIMARY ENDPOINT WAS LOCAL CONTROL. SECONDARY END POINTS INCLUDED DEXAMETHASONE USE AND PROCEDURE-RELATED COMPLICATIONS. RESULTS: BETWEEN 2010 AND 2017, 59 PATIENTS WHO UNDERWENT 74 LITT PROCEDURES FOR 74 PEIRS MET INCLUSION CRITERIA. THE MEAN PRE-LITT PEIR SIZE MEASURED 3.4 ± 0.4 CM3. AT A MEDIAN FOLLOW-UP OF 44.6WK POST-LITT, THE LOCAL CONTROL RATE WAS 83.1%.MOST PATIENTS WERE WEANED OFF STEROIDS POST-LITT. PATIENTS EXPERIENCING A POST-LITT COMPLICATION WERE MORE LIKELY TO REMAIN ON STEROIDS INDEFINITELY. THE RATE OF NEW PERMANENT NEUROLOGICAL DEFICIT WAS 3.4%. CONCLUSION: LITT IS AN EFFECTIVE TREATMENT FOR LOCAL CONTROL OF PEIRS AFTER RADIOSURGERY FOR METASTATIC BRAIN DISEASE. WHEN POSSIBLE, WE RECOMMEND OFFERING LITT ONCE PEIRS ARE IDENTIFIED AND PRIOR TO THE INITIATION OF HIGH-DOSE STEROIDS FOR SYMPTOM RELIEF. 1 PATIENT WITH POST-PROCEDURE LEFT HEMIPARESIS TREATED WITH 4 MG TWICE WEEKLY DEXAMETHASONE WITH PARTIAL RESOLUTION AT LAST FOLLOW-UP. DECEASED, CAUSE AND HOW LONG AFTER PROCEDURE UNKNOWN. 1 PATIENT WITH POST-PROCEDURE EXPRESSIVE APHASIA TREATED WITH 4 MG TWICE DAILY DEXAMETHASONE WITH COMPLETE RESOLUTION AT LAST FOLLOW-UP. DECEASED, CAUSE AND HOW LONG AFTER PROCEDURE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874086 VISUALASE LASER INSTRUMENT, SURGICAL, POWERED GEX MEDTRONIC NAVIGATION, INC 002-1100

    Patients

    Seq Age Sex Outcome Treatment
    1 Death